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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
McKinsey
Accenture
Cerilliant
AstraZeneca
Citi
McKesson
Fish and Richardson
Johnson and Johnson

Generated: April 22, 2018

DrugPatentWatch Database Preview

GLAXOSMITHKLINE Company Profile

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Summary for GLAXOSMITHKLINE
International Patents:1016
US Patents:54
Tradenames:115
Ingredients:96
NDAs:164
Drug Master File Entries: 8

Drugs and US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes 7,776,895 ➤ Sign Up Y ➤ Sign Up
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No 7,919,115 ➤ Sign Up Y Y ➤ Sign Up
Glaxosmithkline THORAZINE chlorpromazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 011120-016 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Glaxosmithkline SUDAFED 12 HOUR pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 017941-002 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 6,294,572 ➤ Sign Up
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-003 Sep 4, 2003 5,681,588 ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 4,816,470*PED ➤ Sign Up
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-001 Sep 4, 2003 5,681,588 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 6 mg ➤ Subscribe 2009-07-22
➤ Subscribe Tablets 250 mg/100 mg ➤ Subscribe 2009-04-03
➤ Subscribe Tablets 62.5 mg/25 mg ➤ Subscribe 2010-09-14
➤ Subscribe Tablets 100 mg ➤ Subscribe 2007-10-31
➤ Subscribe Capsules 60 mg ➤ Subscribe 2010-09-08
➤ Subscribe Extended-release Capsules 225 mg and 425 mg ➤ Subscribe 2006-10-11
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Extended-release Tablets 4 mg ➤ Subscribe 2008-10-31
➤ Subscribe Gum 2 mg ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 2004-12-22
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Extended-release Tablets 2 mg ➤ Subscribe 2008-10-14
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL (prefilled syringes) ➤ Subscribe 2006-05-09
➤ Subscribe Oral Suspension 750 mg/5 mL ➤ Subscribe 2009-10-20
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2007-10-29
➤ Subscribe Capsule 0.5 mg/0.4 mg ➤ Subscribe 2010-10-26
➤ Subscribe Extended-release Capsules 325 mg ➤ Subscribe 2006-11-07
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 2009-12-21
➤ Subscribe Tablets 150 mg ➤ Subscribe 2007-10-30
➤ Subscribe Extended-release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg ➤ Subscribe 2014-02-12
➤ Subscribe Extended-release Tablets 8 mg ➤ Subscribe 2008-11-03
➤ Subscribe Gum 4 mg ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2005-02-04
➤ Subscribe Extended-release Tablets 12 mg ➤ Subscribe 2009-02-05
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL vials ➤ Subscribe 2004-10-25

Non-Orange Book US Patents for GLAXOSMITHKLINE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,073,768 Device and method for setting a frame ➤ Sign Up
7,575,130 Indicating device ➤ Sign Up
7,984,826 Indicating device ➤ Sign Up
7,144,845 Compounds useful in the manufacture of an anti-inflammatory androstane derivative ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0343 Netherlands ➤ Sign Up 300343, 20210803, EXPIRES: 20230110
C/GB08/005 United Kingdom ➤ Sign Up SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
00095 Netherlands ➤ Sign Up PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
2000 00018 Denmark ➤ Sign Up PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Merck
Cerilliant
Chubb
UBS
Covington
Mallinckrodt
Express Scripts
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.